DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
FDA 510(k) clearance K931029 · decided 1994-08-25
Clearance details
- K-number
- K931029
- Device name
- DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
- Applicant
- Chalgren Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-01
- Decision date
- 1994-08-25
- Days to decision
- 542 days
- Clearance type
- Traditional
- Product code
- IKT
- Device class
- 2
- Regulation number
- 890.1385
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Gilroy, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.